We are looking for a Senior QA Partner to join our teams in Bern and provide quality oversight for Maintenance & Utilities, Quality Control, Warehouse, and related operational activities.
Your Responsibilities
Ensure routine and non-routine quality oversight activities in collaboration with local Maintenance & Utilities, Quality Control, Warehouse, and internal transport units.
Act as QA partner for operational quality management according to cGMP, ensuring that all services provided to the Value Streams meet required quality standards and comply with CSL procedures.
Review and approve complex GxP records, including qualification documentation in Opex projects, periodic requalification activities, and operational quality documentation.
Support and approve complex quality risk assessments, non-conformances, investigations, CAPAs, and change controls, while monitoring related quality performance metrics and driving improvements.
Provide QA expertise in global and cross-functional projects, from project management through to project realization.
Serve as Subject Matter Expert during inspections and audits, particularly for deviations and changes, while supporting global QA Support Functions.
Ensure quality oversight of warehouse operations (GDP compliance), QC laboratory activities (QA QC), and Maintenance & Utilities (QA CQV/ENG for utilities).
Your Profile
Degree in Life Sciences, Pharmacy, Engineering, or a related discipline.
Senior-level experience in Quality Assurance within the pharmaceutical industry, ideally as QA Partner or QA Manager.
Strong expertise in QA oversight of Maintenance & Utilities, QC laboratories, and warehouse/distribution operations.
In-depth knowledge of cGMP, GDP, GxP requirements, and regulatory expectations for pharmaceutical manufacturing and operations.
Proven ability to manage complex quality issues including deviations, investigations, CAPAs, risk assessments, and change controls.
Experience with project management and participation in global, cross-functional initiatives.
Excellent communication skills, with the ability to act as SME during inspections and audits.
Collaborative, structured, and proactive mindset with the capacity to support both local and global QA activities.
English and German is mandatory